What goes into a study P&L?
| Revenue | Costs |
|---|---|
| Startup fee | Startup labor: regulatory, contracts, training |
| Per patient visit payments | Coordinator and investigator time per visit |
| Screen failure payments | Unpaid screen failure work beyond the cap |
| Invoiceables: amendments, storage, monitor changes | Recruitment: outreach, ads, events |
| Holdback released at closeout | Overhead: rent, systems, insurance, administration |
What does a worked example look like?
- Startup fee $5,000; startup labor $8,000.
- Budget per completed patient $12,000; direct cost per patient $7,000 in staff time and procedures.
- Recruitment and other fixed study costs $6,000.
- Fixed costs not covered by the startup fee: $8,000 + $6,000 minus $5,000 = $9,000.
- Contribution per completed patient: $12,000 minus $7,000 = $5,000.
- Breakeven: $9,000 ÷ $5,000 = 1.8, so two completed patients, before overhead.
Add overhead, and adjust for dropout (19.1% on average, per Tufts CSDD) and screen failures, and the real breakeven usually rises to several enrolled patients.
Where do study P&Ls go wrong?
- Unpaid screen failures: 88% of sites say they are not sufficiently covered (SCRS).
- Self funded recruitment: 53% of sites pay for it themselves (SCRS).
- Cash timing: holdbacks of 10% to 14% are common (IntuitionLabs, citing SCRS).
- Missing overhead: institutions publish rates such as Penn's 39% (Penn Medicine); see overhead rates.
What is the single biggest lever?
Enrollment above breakeven. Every patient past breakeven contributes most of their budget to profit, which is why the same study can lose money at one site and be among the most profitable at another. Use the revenue per patient calculator to model each study before signing.
Get your study in front of the right local physicians
TrialNotice builds a physician referral pipeline around one active study. We identify relevant local physicians within driving distance of your site, send study aligned direct mail, follow up by email and LinkedIn, track engagement with recipient level QR codes, and route warm responses into your site team's workflow.
Talk to TrialNoticeSources
- Society for Clinical Research Sites, Site Finances White Paper (2024)
- SCRS 2024 Global Site Landscape results, Site Solutions Summit
- IntuitionLabs, "Clinical Trial Site Payment Benchmarks 2026" (citing the SCRS 2023 Site Landscape Survey)
- University of Pennsylvania Perelman School of Medicine, Budget Preparation and Development
- Applied Clinical Trials, "Can Recruitment and Retention Get Any Worse?" (Tufts CSDD screen failure study)
